FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1943873
·
Received December 28, 2010
Report
- Report Number
- 3004209178-2010-10784
- Event Type
- Injury
- Date Received
- December 28, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 21, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE NEUROSTIMULATOR WAS REMOVED DUE TO INFECTION. THE LEAD REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention | ACCESSORY: MODEL 37752, LOT# NKA147343N| LEAD: MODEL 39565-65, LOT# V574039029| PROGRAMMER: MODEL 37743, LOT# NKE159696N| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 265250001| IMPLANTED: |